FDA.reportPublic FDA data

ENVISION ENDOSCOPY INC.

Matched from indexed company URL: ENVIS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
ENVISION ENDOSCOPY INC.5N2026-01-01204 Second Ave Waltham MA US 02451
30147494603014749460Envista (Suzhou) Medical Device Co., Ltd.1N2026-01-011st floor 2nd floor Building 18#, No.8 Jinfeng Road Suzhou Jiangsu CN 215163
00ENVISION ENERGY CO., LTD5N2020-04-25No.3 Shenzhuang Road, Jiangyin Wuxi Jiangsu CN 214400
30092615823009261582EnvisionTEC Inc.1Y2020-04-2515162 S Commerce Dr Dearborn MI US 48120

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04260683220041E-Guard Blue - E-Guard Blue is a light-curing material for the additive manufacturing of individual dental bite splints+49204398750info@envisiontec.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3513492005049571K243750SimpleStitch Suturing SystemOCW2025-04-17
3513491915062675K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter (SC500230)OCZ2024-12-20
2025991619211114
2491321926877547
2025992043731527
2915361303563594
2915361330944091
2915361453048818
2915361486609531
2915361668530861
2915361835048545

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OCW12025-04-17
OCZ12024-12-20

PMN#

E-Temp

2021-06-14

Envisiontec GmbH

GUDID#